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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number MD800F
Device Problems Occlusion Within Device (1423); Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616)
Patient Problems Death (1802); Edema (1820); Thrombus (2101)
Event Date 04/28/2013
Event Type  Death  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only event reported to date for this lot number and failure mode. Investigation summary: the device was not returned for evaluation and images were not provided for review. However, medical records were provided and reviewed. Approximately two months post filter deployment, ct imaging performed to rule out pulmonary embolism demonstrated no evidence of pulmonary thromboembolism; however, a 4 x 1 cm posterior eccentric intraluminal filling defect in the distal superior vena cava (svc) suggestive of an embolus was identified. Approximately three years post filter deployment, the patient was assessed to have chronic bilateral lower extremity edema due to a malpositioned filter that was occluded and was scheduled for consultation and removal of the filter. No further information was provided in the medical records confirming that the filter was tilted or occluded or how the assessment was made. It is also unknown if the filter was removed. Therefore, the investigation is inconclusive for the alleged malpositioned filter and occlusion within the filter. It can be confirmed that the patient experienced thrombus above the filter after filter implantation, however the origin of the thrombus is unknown and the relationship to the filter has not been established in the provided medical records. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications movement, migration or tilt of the filter are known complications of vena cava filters. Filter malposition, caval thrombosis/occlusion. Note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.
 
Event Description
It was reported that a vena cava filter was successfully deployed for a history of deep vein thrombosis. Approximately two months post filter deployment, ct imaging demonstrated thrombus above the filter. Approximately three years post filter deployment, it was indicated that the patient had chronic bilateral lower extremity edema due to the malpositioned and occluded filter. The patient was scheduled for consultation regarding removal of the filter.
 
Manufacturer Narrative
No medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. Medical records were received and reviewed and the investigation of the reported event is currently underway. Medical records review: the patient with deep venous thrombosis was scheduled for placement of an inferior vena cava (ivc) filter. The right femoral vein was accessed and an inferior venacavogram demonstrated no evidence of intraluminal filling defects. The ivc was normal in size and caliber without evidence of duplication. The filter was then deployed in an appropriate position in the ivc without incident. The patient tolerated the procedure well. Approximately two months post filter deployment, ct imaging performed to rule out pulmonary embolism demonstrated no evidence of pulmonary thromboembolism; however, a 4 x 1 cm posterior eccentric intraluminal filling defect in the distal superior vena cava (svc) suggestive of an embolus was identified. Approximately two years one month post filter deployment, ct imaging demonstrated resolution of the filling defect in the distal svc, and noted the filter in place. Approximately two years six months post filter deployment, ct imaging demonstrated the filter in the infrarenal position and the ivc caudal to the filter was diminished in size with a diameter of approximately 5 mm. Approximately three years post filter deployment, the patient was assessed to have chronic bilateral lower extremity edema due to the filter that was malpositioned and occluded and was scheduled for consultation and removal of the filter. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that a vena cava filter was successfully deployed for a history of deep vein thrombosis. Approximately two months post filter deployment, ct imaging demonstrated thrombus above the filter. Approximately three years post filter deployment, it was indicated that the patient had chronic bilateral lower extremity edema due to the malpositioned and occluded filter. The patient was scheduled for consultation regarding removal of the filter.
 
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Brand NameMERIDIAN FILTER SYSTEM - FEMORAL
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key6836844
MDR Text Key250646508
Report Number2020394-2017-01070
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2013
Device Catalogue NumberMD800F
Device Lot NumberGFWJ1341
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/31/2017 Patient Sequence Number: 1
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